Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novartis

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.

Official title: A Twelve-Week, Randomized, Double-Blind, Parallel-Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in diastolic blood pressure after 12 weeks

Secondary outcome:

Change from baseline in systolic blood pressure after 12 weeks

Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks

Blood pressure of < 140/90 mmHg after 12 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Outpatients 18 years of age and older.

2. Patients with essential hypertension.

Exclusion Criteria:

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Other protocol-defined inclusion/exclusion criteria may apply

Investigative Centers, Germany

Novartis, Basel, Switzerland

Starting date: November 2005
Last updated: November 9, 2006